2. Health care utilization and impact on productivity - number of days lost from work, hospitalizations, emergency room visits, unscheduled doctor's visits within 3-6 months following immunization [ Time Frame: 21 days ] [ Designated as safety issue: No ]

This was a Phase II prospective, single-blind to dose, randomized study that compared the immunogenicity of subjects receiving half-dose Fluzone® compared to full-dose Fluzone®, 2004-2005 formulation. 1440 healthy subjects, ages 18-64 years old and not currently indicated for influenza vaccination under the interim ACIP guidelines, were stratified by age, gender, and previous exposure to influenza vaccine, and randomized to receive either half-dose Fluzone® or full-dose Fluzone®.

Eligibility

Ages Eligible for Study:

18 Years to 65 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

• Able to understand and comply with all study procedures including availability for all study visits and follow up surveys within 6 months following study enrollment.

Age 18-49

Patients presenting to travel clinic with no exclusion criteria;

Household contacts and out-of-home caretakers of infants from 6-23 months of age;

Hospital and/or employees providing service to the public who are not eligible for the post-October 5th recommendations for priority immunization;

DOD employees eligible for influenza vaccination prior to October 5th but excluded in the post October 5th guidelines;

People living in dormitories or under other crowded conditions, to prevent outbreaks;

Ages 50-64 years of age who are not eligible for the post-October 5th recommendations for priority immunization and with no standard of care contraindications to vaccination.

Eligible in the Department of Defense for influenza vaccination

Exclusion Criteria:

• all children aged < 18 years (includes children aged 6 months-18 years on chronic aspirin therapy);

out-of-home caregivers and household contacts of children aged <6 months.

Anyone with clinical contraindications for receiving the inactivated influenza vaccine such as a history of severe allergic reaction to prior influenza vaccinations, severe allergy to egg and/or egg proteins and gelatin.

DOD Priority 1: Deployed or deploying (with orders) service members and others designated as critical to national defense.

Any acute or chronic condition that, in the opinion of the investigator or her provider designee would render vaccination unsafe or interfere with the evaluation of the response.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283283